FDA Device recall Z-1921-2024
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286…
- FDA Device
- Class I
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class I recall of Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286… by Thoratec, citing system monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1921-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-08 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thoratec |
| Distribution | US |
Product
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Reason
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Identifiers
| code_info | UDI-DI: 00813024010142, 00813024010852. All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1921-2024%22
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